Health Condition 1: E108- Type 1 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: Allogenic Fecal Microbiota Transplantation: FMT is delivered via colonoscopy into the caecum or terminal ileum. In this study, two sessions (as per protocol) will be planned.
Control In
Sponsors
Indian Council of Medical Research Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Patients diagnosed with T1D duration less than 5 years with detectable C-peptide level No antibiotic use in the last 3 months No history of gastrointestinal diseases or recent infections
Exclusion criteria
Exclusion criteria: Inability to provide written informed consent Evidence for absent residual beta cell function undetectable C-peptide Antibiotics use in the last 3 months and proton pump inhibitor use Presence of other autoimmune disorders Use of immunosuppressive medications Pregnancy or with a pregnancy plan Severe diabetic complications or active infections severe organ dysfunction (including decompensated cirrhosis, malignant tumors etc.) History of any probiotic supplement drug and no history of any probiotic supplement drug intake in last 8 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in gut microbial and metabolites composition from baseline to 12 months post-FMT (including microbial diversity indices and relative abundance of key taxa).Timepoint: Baseline, 3 months, 6 months, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in frequency of regulatory T cells (CD4+CD25+FoxP3+) and level of pro and anti-inflammatory markers from baseline to 12 months post-FMTTimepoint: Baseline, 3 months, 6 months, 12 months | — |
Countries
India
Contacts
Public ContactPriyam Batra
All India Institute of Medical Sciences
Outcome results
None listed